Home NDC 41520-602 Sinus and Allergy PE
Product NDC 41520-602
11-digit product format 415200602
Labeler code 41520
Product ID 41520-602_13f13381-7af4-260f-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name CHLORPHENIRAMINE MALEATE and PHENYLEPHRINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler American Sales Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-07-01
Marketing end 0000-00-00
Substance CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 4 mg/1; mg/1
NDC exclude flag E
Listing certified through 2018-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 44 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 41520-602-02 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 41520-602-02 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 41520-602-02 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 41520-602-02 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 41520-602-02 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 41520-602-02 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 41520-602-02 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 41520-602-02 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 41520-602-02 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 41520-602-02 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 41520-602-02 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 41520-602-02 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 41520-602-02 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 41520-602-02 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 41520-602-02 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 41520-602-02 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 41520-602-02 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 41520-602-02 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 41520-602-02 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 41520-602-02 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 41520-602-02 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 41520-602-02 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41520-602-02 Sinus and Allergy PEMaximum Strength 12 in 1 BLISTER PACK TABLET, COATED 12 2 41520-602-02 Sinus and Allergy PEMaximum Strength 2 in 1 CARTON TABLET, COATED 2 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CHLORPHENIRAMINE MALEATE ACTIVE INGREDIENT V1Q0O9OJ9Z SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 CHLORPHENIRAMINE ACTIVE MOIETY 3U6IO1965U SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 SODIUM STARCH GLYCOLATE TYPE A CORN INACTIVE INGREDIENT AG9B65PV6B SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41520-602 SINUS AND ALLERGY PE MAXIMUM STRENGTH (CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [AMERICAN SALES COMPANY] 2 Legacy NDC, 2 package rows 20150418_364ec875-1da6-4839-a521-e267e810e8fa.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 41520-602-02 41520060202 12 in 1 BLISTER PACK Historical